To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on January 6, 2015.

42 CFR Part 493

Summary

This proposed rule would amend the Clinical Laboratory Improvement Amendments (CLIA) regulations to clarify that the waived test categorization applies only to non-automated fecal occult blood tests. In addition, the proposed rule would remove the hemoglobin by copper sulfate method from the list of waived tests if commenters confirm that the method is no longer used.